Maria Memmolo

Background

About Maria Memmolo

SUMMARY STATEMENT • Scientist with Lean/Design for Six Sigma (DFSS) Green Belt, 17+ years’ experience in the laboratory with over 10 years in the pharmaceutical field. Additional training includes: Business Intelligence and Analytics (Master’s degree in progress 15 out of 30 credits completed), Pfizer Human Performance Excellence Training -Root Cause Analysis Method 1 Training, Change Control Practices-Avoiding Unintended Consequences of Changes (2Day in-person Seminar) • Organizes and drives laboratory instrument qualifications and decommissions projects to meet the needs within R&D Building, Data Integrity remediation, and audit readiness. Communicating goals and progress to system owners and management through organizing meetings, preparing materials for presentation, and documenting actions taken. • Effectively uses cross functional experience in support of and to achieve business, group and individual goals. • Lead Process Improvement Team and Applied Lean Manufacturing Techniques to eliminate waste and improve productivity within the laboratory environment and other continuous improvement projects. • Committed to continuous improvement of performance within the lab environment, to solve problems, and implement solutions to improve operational performance using Lean Six Sigma Methods. • Designed and executed testing protocols. • Summarized studies and test results to present results in report format or as a presentation. • Managed Change Controls for qualification of instruments within the Good manufacturing Practices (cGMP) laboratories. • Responsible for creating all applicable qualification documentation for instrument installation to guarantee consistency and compliance with Pfizer, FDA and Data Integrity guidelines. • Managed instrument installation projects within the laboratories. Managed smaller laboratory projects. • Assisted in Identifying root causes and coordinated corrective actions for laboratories investigations. • Good working knowledgeable of cGMPs, and FDA guidelines. • Experienced in Microsoft Office and statistical software such as JMP and Minitab.